On-site audit

Postaudit Process The postaudit process consists of preparation of a draft report, preparation of a final report, development of artion plans, and follow-up. A draft report of the audit findings should be prepared shortly after the completion of the on-site audit. The draft report usually undergoes review and comment by facility personnel involved with the audit, experienced auditors not involved with the subject audit, functional specialists, and attorneys. The review of the draft report is done to assure that a clear, concise, and accurate report is issued, and not to modify or change the findings. Once this review procedure is completed, a final report can be issued and distributed based on a distribution list provided by the facility personnel. The final audit report should be issued in a timely manner and meet the time requirement specified in the audit plan. 

Each on-site audit, including initial and surveillance audits, shall include a review of supplier internal audit and management review results and actions and progress made toward continuous improvement targets. 

Surveys often involve questionnaires that are completed by facility staff. Surveys can be used in place of any on-site audits however, this precludes your gaining first-hand Imowledge of the PSM systems and leaves you unable to vouch for the accuracy of the information gathered. 

Support for sites is multi-tiered and includes participation by numerous federal, state, private, academic, and tribal organizations. Network operation includes rigorous field and laboratory quality assurance/quality control (QA/QC), including an external quality assurance program and periodic external on-site audits. 

The reporting step of the on-site audit should be planned to avoid any surprises to facility personnel. Reporting sessions should be held at the end of each audit day to inform facility personnel of the findings, clear up any misunderstandings of the data, and help redirect... 

The quality assurance manager or the system in charge may perform an on-site audit. The audit should specihcally ... 

Before starting an on-site audit, plan the audit. Review past audits, note indications of possible problem areas and items, if any, that were identified for corrective action in a previous audit. If you are not already familiar with this facility, learn the type of product produced and how it is organized by personnel and function. What does your customer, that is, your superior or senior facility management, expect to learn from this audit ... 

Step 9 Method maintenance Incorporate the new method or analyzer into the existing method maintenance systems for the site, to ensure that the method as practiced continues to meet the technical requirements for as long as it is in use. This is done by the receiver. Method maintenance systems may include check sample control-charting, intra-and/or inter-lab uniformity testing, on-site auditing, instrument preventive maintenance (PM) scheduling, control-charting the method precision and/or accuracy, etc. 

Type of vendor supplier background Reference financial check conducted Not required Question- naire audit On-site audit annually On-site audit (during each event) 100% testing upon receipt of deliverable Minimal testing upon receipt of deliverable No testing upon receipt of deliverable No history of quality concerns History of quality concerns Category of vendor supplier... 

In lieu of testing by the procurement agency, a certificate of analysis may be accepted from the supplier, provided that the agency establishes the reliability of the supplier s analysis through appropriate periodic validation of the supplier s test results and through on-site audits of the supplier s capabilities. 

---